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Corticosteroid

PARTICS for Asthma (PREPARE Trial)

Phase 4
Waitlist Available
Led By Elliot Israel, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly through study completion an average of 15 months
Awards & highlights

PREPARE Trial Summary

Asthma imposes a significant burden in the US in terms of morbidity, costs to society, individual suffering, loss of productivity and mortality. African Americans (AA) and Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national guidelines for asthma treatment, the gap between these groups and whites has been stable or widening. The need for pragmatic research to address the continuing burden is widely recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis, in all but the mildest asthma. However, adherence by patients and implementation of evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests that it is difficult to improve adherence to the current recommendations without complex and resource-intensive interventions. Studies have examined symptom-activated use of ICS triggered by use of a reliever medication. The Investigators call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with usual care, while reducing ICS use by half or more. These studies have been performed in pre-selected populations, which represent less than 5% of asthma patients. The previous studies have been done with repeated education and adherence checks in both the intervention and control arms. The investigators have consulted with AA and H/L patients, health care providers, leaders of professional societies, advocacy groups, health policy leaders, pharmacists, and pharmaceutical manufacturers. All groups have indicated that asthma decision making would be changed if we demonstrated that implementing PARTICS improves important asthma outcomes such as reducing exacerbations. The Investigators have designed a study with the stakeholders to determine whether PARTICS can improve outcomes that are important to patients when superimposed on a background provider-educated standard of care through the Asthma IQ system. The Investigators propose a study entitled PREPARE: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The Investigators aim to determine whether PARTICS can reduce asthma morbidity in AA and H/L.

PREPARE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly through study completion an average of 15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly through study completion an average of 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Asthma Exacerbations Per Year
Secondary outcome measures
Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline
Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma
Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline

PREPARE Trial Design

2Treatment groups
Active Control
Group I: PARTICSActive Control1 Intervention
addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use
Group II: Usual CareActive Control1 Intervention
Provider-enhanced usual care arm; no change in asthma management

Find a Location

Who is running the clinical trial?

American Academy of Family PhysiciansOTHER
12 Previous Clinical Trials
30,865 Total Patients Enrolled
2 Trials studying Asthma
472 Patients Enrolled for Asthma
Brigham and Women's HospitalLead Sponsor
1,614 Previous Clinical Trials
11,469,615 Total Patients Enrolled
41 Trials studying Asthma
214,756 Patients Enrolled for Asthma
Patient-Centered Outcomes Research InstituteOTHER
550 Previous Clinical Trials
29,995,728 Total Patients Enrolled
14 Trials studying Asthma
3,048,657 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~164 spots leftby Apr 2025